Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cosine-10TM Diagnostic Catheter

K-Number: K233397 · 2023-12-02

ApplicantMedtronic, Inc.
Decision Date2023-12-02
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cosine-10TM Diagnostic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-12-02 under 510(k) number K233397. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cosine-10TM Diagnostic Catheter?

Cosine-10TM Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2023-12-02. The listed applicant is Medtronic, Inc.. The 510(k) number is K233397.

When did Cosine-10TM Diagnostic Catheter receive FDA 510(k) clearance?

Cosine-10TM Diagnostic Catheter received FDA 510(k) clearance on 2023-12-02, under 510(k) number K233397.

Who is the listed applicant for Cosine-10TM Diagnostic Catheter?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cosine-10TM Diagnostic Catheter?

The FDA product code for Cosine-10TM Diagnostic Catheter is DRF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

Other records listing Medtronic, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P960009Stimulator, electrical, implanted, for parkinsonian tremorPMA P860004Pump, infusion, implanted, programmablePMA P130021Aortic valve, prosthesis, percutaneously deliveredPMA P240013Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationPMA P100047Ventricular (assist) bypassPMA P980035Pulse generator, permanent, implantable

View all 166 devices →

Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationPMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑